Multiple dose delivery device with manually depressible actuator and one-way valve for storing and dispensing substances, and related method

ABSTRACT

A dispenser has a body with a variable-volume storage chamber for storing substance, and a dispensing portion defining a dosage chamber in fluid communication with the storage chamber. A first valve includes a valve seat and a flexible valve cover seated thereon defining a normally-closed fluid-tight seam therebetween. The valve cover relative to moves from the valve seat to allow substance through the seam and out of the dispenser. A second valve allows substance from the storage chamber into the dosage chamber and substantially prevents flow from the dosage chamber into the storage chamber. An actuator is manually movable between (i) a first non-actuated position, and (ii) a second actuated position extending into the dosage chamber for compressing a dose of substance therein, dispensing substance through the first valve. The elasticity of the actuator causes it to return to the first non-actuated position upon manually releasing the actuator.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application claims priority on U.S. provisional patentapplication Ser. No. 60/858,155, filed Nov. 11, 2006, which is herebyexpressly incorporated by reference in its entirety as part of thepresent disclosure.

FIELD OF THE INVENTION

The present invention relates to dispensers for containing anddispensing fluids and other substances, such as pharmaceutical,cosmeceutical, cosmetic, food and beverage products, and moreparticularly, to dispensers for holding multiple doses of such fluidsand other substances, and that include one-way valves for hermeticallysealing the substances within the dispensers, and manually engageableactuators for dispensing doses of substances through the one-way valves.

BACKGROUND INFORMATION

Prior art dispensers for storing and dispensing multiple doses ofsubstances, such as cosmetic dispensers for dispensing, for example,liquid lipstick or eye shadow, ophthalmic dispensers for dispensingophthalmic products, such as eye drops, pharmaceutical dispensers fordispensing pharmaceutical products, food and beverage dispensers fordispensing food or beverage products, typically do not store theproduct, which may take the form of a liquid, cream, gel, suspension orother format, in a hermetically sealed storage chamber. In addition,such dispensers may be exposed to, and/or are applied to a user's facialor other body surfaces, or to other elements, that may contain dirt,germs, bacteria or other unwanted contaminants. Such contaminants canpenetrate through the dispensing openings in the dispensers and, inturn, contaminate the bulk of the products stored within the dispensers.As a result, the contaminants can be passed from one user to another orotherwise cause unhealthy conditions with further usage of thedispensers. Further, because the products stored within the dispensersare exposed to air, the products can degrade or spoil, and/or requirepreservatives to prevent such degradation and/or spoilage fromoccurring. In some circumstances, preservatives can cause allergicand/or other undesirable or negative reactions, such as unwanteddermatological reactions, or irritation of the eyes, skin or othertissues.

In some dispensers including storage chambers for storing multiple dosesof substances, the storage chambers can define a smaller volume thanotherwise desired. In addition, it can be difficult to increase thevolume of the storage chamber if desired. In other dispensers with pumpsor other mechanisms for propelling a dose from the dispenser, the dosecan spritz when emitted from the dispenser, and this can be undesirablewhen used, for example, for ophthalmic delivery.

It is an object of the present invention to overcome one or more of theabove-described drawbacks and/or disadvantages of the prior art.

SUMMARY OF THE INVENTION

In accordance with one aspect, the present invention is directed to adispenser for dispensing a substance, comprising a body defining avariable-volume storage chamber for storing the substance. A dispensingportion is connected with the body and defines a dosage chamber coupledin fluid communication with the storage chamber for receiving substancetherefrom, and an outlet aperture coupled in fluid communication withthe dosage chamber. A first valve includes an axially-extending valveseat and an axially-extending flexible valve cover seated on the valveseat and defining a normally-closed, axially-extending seam therebetweenforming a fluid-tight seal between the valve cover and valve seat. Theflexible valve cover is movable relative to the valve seat and the seamis connectable in fluid communication with the outlet aperture to allowthe passage of substance through the seam and out of the dispenser. Asecond valve is coupled in fluid communication between the dosagechamber and the storage chamber that allows the flow of substance fromthe storage chamber into the dosage chamber and substantially preventsthe flow of substance from the dosage chamber into the storage chamber.An elastic actuator, such as a manually-engageable actuator, is mountedon the dispensing portion and is movable between (i) a firstnon-actuated position, and (ii) a second actuated position forcompressing a dose of substance within the dosage chamber and, in turn,dispensing the substance through the first valve. The elasticity of theactuator causes the actuator to return from the second actuated positionto the first non-actuated position upon releasing the actuator.

In one embodiment of the present invention, the second valve is a checkvalve. In one such embodiment, the check valve is a flap valve.

In one embodiment of the present invention, the dispensing portionincludes a dispensing body defining the dosage chamber, outlet apertureand valve seat, and the elastic actuator is co-molded to the dispensingbody.

In one embodiment of the present invention, the elastic actuator is influid communication with the dosage chamber, and extends into the dosagechamber in the second actuated position. In one such embodiment, theactuator extends axially in a direction approximately parallel to anaxis of symmetry of the dispenser, and extends angularly about the axisof symmetry. In one such embodiment, the actuator extends angularlythrough an arc within the range of about 50° to about 80°. In one suchembodiment, a manually-engageable surface of the actuator is located asubstantially uniform distance from the axis of symmetry in thenon-actuated position.

In one embodiment of the present invention, the body forming the storagechamber includes a flexible tube. In one such embodiment, the bodyfurther includes a tube head connected to the flexible tube. In one suchembodiment, the tube head is co-molded, such as by insert molding, withthe flexible tube.

In one embodiment of the present invention, the flexible valve cover isresponsive to a flow of substance in the outlet aperture exceeding avalve opening pressure to move between (i) a normally-closed condition,and (ii) an open condition wherein portions of the valve cover axiallyspaced relative to each other substantially sequentially movesubstantially radially relative to the valve seat to allow the passageof substance through the seam and out of the dispenser.

One embodiment of the present invention further comprises a stopperslidably received within the body and forming a substantiallyfluid-tight seal therebetween. The variable-volume storage chamber isformed between the stopper and the dosage chamber, and the stopper ismovable toward the dosage chamber upon dispensing a dose from thestorage chamber to reduce the volume of the storage chamber in an amountapproximately equal to the volume of the dose dispensed. One suchembodiment further comprises a flexible membrane coupled between thestopper and an end portion of the body opposite the dispensing portion,and forming a substantially fluid-tight seal between the annular stopperand respective end portion of the body. In one such embodiment, theflexible membrane includes a plurality of laminated layers. In one suchembodiment, the flexible membrane extends annularly about the stopperand about the respective end portion of the body. In one embodiment ofthe present invention, the stopper includes a needle penetrable andthermally resealable portion.

In accordance with another aspect, the stopper includes at least onerelatively rigid annular sealing portion forming an interference fitwith the body, and at least one relatively flexible annular sealingportion forming an interference fit with the body and a fluid-tight sealtherebetween. In one such embodiment, the relatively rigid andrelatively flexible portions are co-molded. In some such embodiments,the relatively flexible portion further defines a penetrable andthermally resealable portion that is penetrable by a filling member tofill the variable-volume storage chamber and is thermally resealable tothermally reseal an aperture therein. In one such embodiment, theflexible sealing portion is substantially concentric with the penetrableportion, and a gap is formed therebetween.

In one embodiment of the present invention, at least one of the valvecover and the valve seat defines at the seam at least one relativelyraised surface area and at least one adjacent relatively recessedsurface area to prevent spritzing of a dose of the substance uponemission from the valve. In one such embodiment, at least one of thevalve cover and the valve seat defines a plurality of relatively raisedsurface areas and relatively recessed surface areas adjacent torelatively raised surface areas. In one such embodiment, the valve coverincludes a first portion defining a first degree of radial interferencewith the valve seat in the normally closed position, and a secondportion axially spaced relative to the first portion defining a seconddegree of radial interference with the valve seat in the normally closedposition. In one such embodiment, the second degree of radialinterference is less than the first degree of radial interference. Inone such embodiment, the second degree of radial interference isapproximately zero or less. Also in one such embodiment, the secondportion is located outwardly on the first valve relative to the firstportion.

In one embodiment of the present invention, the valve cover extendsannularly about the valve seat, and the dispenser further comprises asecuring member fixedly connected to the dispensing portion andcompressing a portion of the valve cover therebetween to, in turn, forma fluid tight seal between the valve cover and the dispensing portion.The securing member extends annularly about the valve cover, and extendsaxially along a substantial portion of the valve cover. In one suchembodiment, a distal portion of the valve cover extends outwardly of thesecuring member.

In accordance with another aspect, the present invention is directed toa dispenser for dispensing a substance, comprising:

first means for forming a variable-volume storage chamber for storingthe substance;

second means for forming a dosage chamber coupled in fluid communicationwith the storage chamber for receiving substance therefrom, and anoutlet aperture coupled in fluid communication with the dosage chamber;

third means for forming a normally-closed, axially-extending seamcoupled in fluid communication with the second means and movable inresponse to the flow of pressurized substance from the second means intothe seam to allow the passage of substance through the seam and out ofthe dispenser;

fourth means coupled in fluid communication between the dosage chamberand the storage chamber for allowing the flow of substance from thestorage chamber into the dosage chamber and substantially preventing theflow of substance from the dosage chamber into the storage chamber; and

fifth means for engaging and elastically moving between (i) a firstnon-actuated position, and (ii) a second actuated position forcompressing a dose of substance within the dosage chamber and, in turn,dispensing the substance through the third means, and for elasticallyreturning from the second actuated position to the first non-actuatedposition upon releasing the fifth means.

In one embodiment of the present invention, the first means is a bodyportion of the dispenser; the second means is a dispensing portionconnected with the body and defining a dosage chamber coupled in fluidcommunication with the storage chamber for receiving substancetherefrom, and an outlet aperture coupled in fluid communication withthe dosage chamber; the third means is a first valve including anaxially-extending valve seat and an axially-extending flexible valvecover seated on the valve seat and defining a normally-closed,axially-extending seam therebetween forming a fluid-tight seal betweenthe valve cover and valve seat, wherein the flexible valve cover ismovable relative to the valve seat and the seam is connectable in fluidcommunication with the outlet aperture to allow the passage of substancethrough the seam and out of the dispenser; the fourth means is a secondvalve coupled in fluid communication between the dosage chamber and thestorage chamber that allows the flow of substance from the storagechamber into the dosage chamber and substantially prevents the flow ofsubstance from the dosage chamber into the storage chamber; and thefifth means is an elastic actuator mounted on the dispensing portion influid communication with the dosage chamber and movable between (i) afirst non-actuated position, and (ii) a second actuated position forcompressing a dose of substance within the dosage chamber and, in turn,dispensing the substance through the first valve.

In one embodiment of the present invention, the dispenser furthercomprises sixth means for substantially preventing the substance fromspritzing upon being dispensed from the third means. In one suchembodiment, the sixth means is defined by at least one of a valve coverand a valve seat defining at a seam formed therebetween at least onerelatively raised surface area and at least one adjacent relativelyrecessed surface area.

In accordance with another aspect, the present invention is directed toa method comprising the following steps:

providing a sealed, empty device including a body, a slidable stopperreceived within the body and defining a variable-volume storage chambertherein, a one-way valve, a dosage chamber connectable in fluidcommunication between the one-way valve and variable-volume storagechamber, and an actuator movable between a non-actuated position and anactuated position for compressing a dose of fluid within the dosagechamber and dispensing the dose through the one-way valve;

penetrating the stopper with a filling member and the stopper located ina first position within the body;

moving the filling member and stopper to a second position with thebody;

filling the variable-volume storage chamber with a fluid through thefilling member;

moving the filling member and stopper from the second position back tothe first position while filling the variable-volume storage chamber;

withdrawing the filling member; and

thermally sealing an aperture in the stopper to seal the filledvariable-volume storage chamber.

In some embodiments, the method further comprises the step ofsterilizing the sealed empty device prior to filling. Some embodimentsfurther comprise the step of drawing a vacuum through at least one ofthe needle and a filling aperture during the filling step. Someembodiments further comprise drawing with the vacuum source filled fluidout of the variable-volume storage chamber and into a filling memberconduit and/or a collection container coupled in fluid communicationwith the filling member upon filling the chamber, and withdrawing thefilling member to thereby leave substantially zero air within thechamber. Some embodiments further comprise the step of providing anoverpressure of sterile air over at least one of the filling member anddevice during filling.

One advantage of currently preferred embodiments of the presentinvention is that the storage chamber may be defined by a flexible tube,or a rigid body with a sliding stopper or piston received within therigid body. In the flexible tube embodiments, the tubes can take any ofnumerous different shapes or sizes, and the same or substantially thesame type of dispensing portion can be connected to different sizedtubes. As a result, the dispenser can provide significant flexibilitywith respect to storing and dispensing various desired volumes ofsubstances. Another advantage of certain preferred embodiments of thepresent invention, is that the dispenser can deliver substantially onedrop of substance at a time, and the drop can be delivered substantiallywithout spritzing. This can be particularly advantageous in theophthalmic applications of the dispenser. Yet another advantage ofcurrently preferred embodiments of the present invention is thatsubstantially predetermined volumes of substances can be delivered witheach dose. A still further advantage of currently preferred embodimentsof the present invention is that the substance can be retained withinthe storage chamber in a sterile, substantially airless, hermeticallysealed condition during both the shelf life, and during the period ofuse of the dispenser (i.e., throughout the period from dispensing thefirst to the last dose of substance from the storage chamber). Anotheradvantage of such embodiments is that the substance may be preservativefree.

Other objects and advantages of the present invention, and/or of thecurrently preferred embodiments thereof, will become apparent in view ofthe following detailed description of the currently preferredembodiments and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an upper perspective view of a first embodiment of a dispenserof the present invention.

FIG. 2 is a cross-sectional view of the dispenser of FIG. 1.

FIG. 3 is a partial, enlarged, cross-sectional view of the one-way valveof the dispenser of FIG. 1.

FIG. 4 is another partial, enlarged, cross-sectional view of the one-wayvalve of the dispenser of FIG. 1.

FIG. 5 is a partial, enlarged, perspective cross-sectional view ofanother embodiment of the one-way valve of the dispenser of FIG. 1.

FIG. 6 is another partial, enlarged, cross-sectional view of theembodiment of the one-way valve of FIG. 5.

FIGS. 7A-7D are a series of somewhat schematic, cross-sectional views ofthe dispenser of FIG. 1 illustrating the filling of the storage chamberwith a substance by penetrating the needle penetrable and laserresealable stopper of the piston forming the variable-volume storagechamber.

FIGS. 8A-8C are a series of somewhat schematic, cross-sectional views ofthe dispenser of FIG. 1 illustrating the withdrawal of the needle andlaser resealing of the resulting needle hole formed in the stopper tohermetically seal the substance within the variable-volume storagechamber.

FIG. 9 is a side elevational view of the dispenser of FIG. 1illustrating the body as transparent to show exemplary features withinit, the manually-engageable, elastic actuator in the second actuatedposition, and a resulting drop of substance released from the dispensingtip of the one-way valve.

FIGS. 10A-10F are a series of side elevational views of the dispenser ofFIG. 1 illustrating the body as transparent and the manner in which themanually-engageable, elastic actuator is manually depressed to dispensea drop of substance, how the sliding piston correspondingly movesforward to reduce the volume of the storage chamber in an amountapproximately equal to the volume of the drop dispensed, and how theprocess is repeated for the delivery of subsequent doses.

FIG. 11 shows the dispenser of FIG. 1 in an empty condition.

FIG. 12 is an upper perspective view of another embodiment of thepresent invention including a collapsible tube forming thevariable-volume storage chamber, and a dispensing portion defining amore axially-elongated tip in comparison to the dispenser of FIG. 1 fordispensing, for example, creams or gels, onto an eye, nose, ear, etc.

FIG. 13 is a cross-sectional view of the dispenser of FIG. 12.

FIG. 14 is a cross-sectional view of another embodiment of a dispenserof the present invention wherein the penetrable and thermally resealablesliding stopper includes co-molded relatively rigid and relativelyflexible annular sealing portions.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1-11, a dispenser embodying the present invention isindicated generally by the reference numeral 10. The dispenser 10 isparticularly suitable for dispensing fluids and other substances, suchas pharmaceutical, cosmeceutical, cosmetic, ophthalmic, food andbeverage products. However, as may be recognized by those of ordinaryskill in the pertinent art based on the teachings herein, the dispenser10 may be adapted to dispense any of numerous different types of fluidsor other substances that are currently known, or that later becomeknown. As shown typically in FIG. 1, the dispenser 10 includes a body 12defining a variable-volume storage chamber 14 for storing the substance,such as a pharmaceutical, cosmeceutical, cosmetic, ophthalmic, food orbeverage product. A dispensing nozzle or portion 16 is connected withthe body 12 and defines a dosage chamber 18 coupled in fluidcommunication with the storage chamber 14 for receiving the storedsubstance therefrom, and at least one outlet aperture 20 coupled influid communication with the dosage chamber 18. An elastic actuator 22is receivable within the dosage chamber 18, and a dispensing nozzle orone-way valve 24 is mounted on the dispensing portion 16 for dispensingthe stored substance therethrough.

The dispensers disclosed herein are similar to those disclosed in U.S.patent application Ser. No. 11/237,599, entitled “Laterally-ActuatedDispenser with One-Way Valve for Storing and Dispensing Metered Amountsof Substances”, like titled U.S. Provisional Application No. 60/613,583,filed Sep. 27, 2004, and U.S. Provisional Application No. 60/699,607filed Jul. 15, 2005, and U.S. Design Pat. Application No. 29/214,062,filed on Sep. 27, 2004 entitled “Dispenser with Laterally-ActuatedDispensing Valve”, each of which is hereby incorporated by reference inits entirety as part of the present disclosure.

As shown in FIGS. 2-6, the one-way valve 24 includes anaxially-extending valve seat 26, and an axially-extending flexible valvecover 28 seated on the valve seat and defining a normally-closed,axially-extending seam 30 therebetween forming a fluid-tight sealbetween the valve cover 28 and valve seat 26. As described furtherbelow, the flexible valve cover 28 is movable relative to the valve seat26, and the seam 30 is connectable in fluid communication with theoutlet aperture 20 to allow the passage of product through the seam andout of the dispenser.

The actuator 22 is a manually-engageable, elastic actuator that ismounted on the dispensing portion 16 and is manually movable between (i)a first non-actuated position, as shown typically in FIGS. 1 and 2, and(ii) a second actuated position, as shown typically in FIG. 9, forcompressing a dose of substance within the dosage chamber 18 and, inturn, dispensing the substance through the one-way valve 24. Asdescribed further below, the elasticity of the actuator 22 causes theactuator to return from the second actuated position (FIG. 9) to thefirst non-actuated position (FIG. 1) upon releasing the actuator. As canbe seen, the actuator 22 is laterally positioned with respect to theone-way valve 24, is in fluid communication with the dosage chamber 18,extends axially in a direction approximately parallel to an axis ofsymmetry of the dispenser 10, extends angularly about the axis ofsymmetry, and in the second actuated position (FIG. 9) extends into thedosage chamber 18. In one embodiment of the present invention, theelastic actuator 22 extends angularly through an arc within the range ofabout 50° to about 80°. As also shown in the illustrated embodiment, themanually-engageable surface 32 of the actuator 22 is located asubstantially uniform distance from the axis of symmetry in thenon-actuated position (FIG. 2). The actuator 22 defines a drive axis ordirection extending between the non-actuated or rest position of FIG. 1and the actuated position of FIG. 9, and the drive axis is orientedtransverse to the axis of the one-way valve 24 and body 12. In theillustrated embodiment of the present invention, the drive axis of theactuator is oriented at about 90° relative to the axis of the one-wayvalve and body. However, the drive axis may be oriented at any ofnumerous angular orientations in order to facilitate the manufacture ofthe dispenser, to facilitate manipulation or actuation of the dispenser,or otherwise to improve the ergonomics of the dispenser.

As indicated above, the one-way valve 24 includes a relatively rigidvalve seat 26 and a flexible valve cover 28 mounted over the valve seatand defining the axially elongated, annular seam or interface 30therebetween. As described further below, the actuator 22 forces a doseof fluid or other substance at sufficient pressure to open the valve(the “valve opening pressure”) and force the fluid or other substancethrough the valve interface 30 and out of the dispenser. The valve cover28 preferably forms an interference fit with the valve seat 26 tothereby form a fluid-tight seal in the normally closed position and, inturn, maintain the fluid or other substance within the dispenser in asterile and hermetically sealed condition. As shown typically in FIGS. 1and 2, the valve cover 28 may define a substantially taperedcross-sectional shape moving in the axial direction from the interiortoward the exterior of the valve. This configuration requiresprogressively less energy to open each respective annular portion of thevalve when moving axially from the interior toward the exterior of thevalve. Alternatively, or in combination with the tapered valve cover 28,the valve seat 26 may define an outer diameter that progressively orotherwise increases in the axial direction toward the valve tip, toprovide the same or similar effect. As a result, once the base of thevalve 24 is opened, the pressure is sufficient to cause the respectiveaxial segments of the valve cover 28 to progressively open and thenclose after passage of substance therethrough when moving in the axialdirection toward the valve tip to dispense a dose. Also, at any timewhen dispensing a dose, preferably any one of a plurality of differentsubstantially annular segments of the valve cover 28 engages the valveseat 26 to maintain a fluid-tight seal across the valve 24, and therebyprevent ingress through the valve of germs, bacteria or other unwantedsubstances and into the storage chamber 14. The volume of the dose maybe varied depending upon the degree to which the actuator 22 isdepressed when moved from the first non-actuated position (FIG. 2) tothe second actuated position (FIG. 9).

In the illustrated embodiment the dispensing portion 16 includes asingle outlet aperture 20 for each dose. If desired, additional outletapertures may be added (e.g., a second outlet aperture of the same ordifferent size diametrically opposed to the illustrated aperture 20, ora different plurality of substantially equally spaced apertures may beprovided), or the aperture 20 may be moved to a position other than thatshown (e.g., the single outlet aperture may be located on the oppositeside of the valve seat relative to that shown).

The valve seat 26 and dosage chamber 18 are formed integral with eachother on the dispensing portion 16 and are formed of a relatively rigidmaterial. A fluid passageway 34 extends between the storage chamber 14and the dosage chamber 18 for permitting the flow of fluid or othersubstance from the storage chamber 14 into the dosage chamber 18.

A check valve or anti-reflux valve 36 is mounted on the downstream sideof the fluid passageway 34 to prevent substance within the compressionchamber 18 from flowing back into the variable-volume storage chamber 14after depressing the actuator 22. In the illustrated embodiment, thecheck valve 36 is formed integral with the actuator 22, and is definedby a laterally extending lobe or flap 38 that overlies the downstreamside (i.e., the dosage chamber 18 side) of the fluid passageway 34 tonormally close the passageway. As can be seen, as the actuator 22 ismanually depressed, the flap 38 of the check valve 36 is forced againstthe downstream side of the fluid passageway 34 to seal the opening tothe passageway and, in turn, seal the compression chamber 18 withrespect to the variable-volume storage chamber 14, and thereby preventany substance from flowing in the direction from the compression chamber18 back into the variable-volume storage chamber 14 during thecompression stroke of the actuator. When the user releases the actuator22, the inherent elasticity of the actuator 22 drives the actuator backinto the ambient or rest position, as shown typically in FIG. 2. Uponmovement of the actuator 22 from the actuated position (FIG. 9) to therest or ambient position (FIG. 2), the substance in the variable-volumestorage chamber 14 is drawn through the fluid passageway 34, over theflap 38 of the check valve 36, and into the dosage chamber 18 to fillthe dosage chamber for the next dose.

In the illustrated embodiments, the body of the dispensing portion 16 ismade of a relatively hard plastic material, such as any of the plasticssold under the trademarks Topaz™, Surlyn™, and Zeonex™. The valve cover28 and elastic actuator 22, on the other hand, are each made of anelastic or elastomeric material that is relatively soft in comparison tothe body and valve seat 26. For example, the valve cover 28 and actuator22 each may be made of a polymeric material, such as one of thematerials sold under the trademarks Kraton™ or Santoprene™ (e.g.,Santoprene 8211-35 (shore 35 hardness) or 8211-55 (shore 55 hardness)),Rimflex™, such as Rimflex A/AS 25C, Dynaflex G2706, or a vulcanizedrubber or other polymeric material. The actuator 22 is formed of amaterial that defines a radial thickness and durometer such that theactuator has sufficient elasticity to return itself from the secondactuated position (FIG. 9) to the first non-actuated position (FIG. 2)upon release. In one embodiment of the present invention, the actuator22 defines a thickness within the range of about 1 to 3 mm, andpreferably within the range of about 1.5 to about 2 mm, and a durometerwithin the range of about 20 to about 40 shore A, and preferably withinthe range of about 25 to about 35 shore A. Also in the illustratedembodiment, the actuator 22 and check valve 36 are co-molded with thebody of the dispensing portion 12, such as by over-molding the actuatorand check valve to the body. However, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, thesematerials and methods of manufacture are only exemplary, and numerousother materials and methods of manufacture that are currently known, orthat later become known equally may be used.

The dispenser 10 further includes a plunger 40 (also referred to as asliding piston or stopper) that is slidably received within the body 12and axially spaced relative to the actuator 22 and dosage chamber 18 todefine the variable-volume storage chamber 14 therebetween. The plunger40 includes at least one, and preferably two axially spaced, outerannular sealing members or portions 42 that sealingly engage the innerwall 44 of the body 12 to form a fluid-tight seal therebetween. Thesealing members or portions 42 may be formed integral with the plunger40, such as by forming thereon annular protuberances, as shown, thatform a radial interference fit with the inner wall 44, or may be formedby sealing members, such as o-rings or other sealing members, that arereceived within corresponding grooves or recesses formed in the plunger.As the actuator 22 is progressively actuated, the plunger 40 slidesforwardly within the dispenser body 12 (or in the direction of right toleft in FIG. 2) due to the suction forces exerted thereon as the fluidor other stored substance is dispensed from the variable-volume storagechamber 14.

The plunger 40 defines a substantially flat inner surface 46, and asubstantially conical tapered portion 48 extending between the innersurface 46 and the annular sealing surfaces 42. As can be seen, theinner end of the body 12 defines a substantially conically-taperedrecess 50 for receiving therein the plunger 40. When the variable-volumestorage chamber 14 is substantially emptied of the substance storedtherein, the flat surface 46 and conically-tapered portion 48 of theplunger 40 are received within the recess 50 of the body 12. Oneadvantage of this configuration is that it substantially eliminates anydead volume in the dispenser when emptied and thus any waste of productstored therein.

The dispenser 10 further comprises an approximately annular securingmember 52 coupled to the dispensing portion 16 and fixedly securing thevalve cover 28 thereto. The securing member 52 defines an aperture 54extending through a central portion thereof for receiving the dispensingtip of the one-way valve 24 therethrough, an annular,laterally-extending flange 56 formed on the inner end thereof andreceived within a corresponding annular groove 58 formed on thedispensing portion 16 for fixedly securing the securing member 52 andthus the valve cover 28 to the dispensing portion 16, and an annular,axially-extending flange 60 formed on the inner periphery of theaperture 54 that is received within a corresponding annular groove 62formed on the valve cover 28 to compress the valve cover against thedispensing portion and form a fluid-tight seal therebetween. Thedispensing portion includes an annular spike 64 that is pressed intoengagement with the compressed portion of the valve cover 28 to furthereffect a fluid-tight seal between the valve cover and securing member52. The dispensing portion 16 further includes on the end opposite theone-way valve 24 a connecting portion 66 including an annular,laterally-extending flange 68 that is received within a correspondingannular groove 70 formed on the body 12 to fixedly secure the dispensingportion 16 to the body 12.

The one-way valve 24 preferably further includes means for substantiallypreventing the substance from spritzing upon being dispensed (or uponemission) from the one-way valve 24. In the illustrated embodiments,such means takes the form of at least one of the valve cover 28 and thevalve seat 26 defining at the seam 30 formed therebetween at least onerelatively raised surface area 74 and at least one adjacent relativelyrecessed surface area 76. In the embodiment of FIGS. 3 and 4, the valvecover 28 defines plurality of relatively raised surface areas 74 thatare axially spaced relative to each other, and a plurality of relativelyrecessed surface areas 76 formed therebetween. Also in the illustratedembodiment, the relatively raised surface areas 74 are defined byannular rings, and the relatively recessed surface areas 76 are definedby corresponding annular grooves. As shown in FIGS. 3 and 4, the one-wayvalve 24 defines an axially-extending region 78 of radial interferenceat the seam 30 between the valve cover 28 and valve seat 26 to effectthe fluid-tight seal therebetween in the normally closed position. Inthe illustrated embodiment, the valve cover 28 and valve seat 26 definea first axially-extending portion 80 forming a first degree of radialinterference in the normally closed position, and a secondaxially-extending portion 82 axially spaced relative to the firstportion 80 forming a second degree of radial interference in thenormally closed position. In the embodiment of FIGS. 3 and 4, the seconddegree of radial interference at the second portion 82 is less than thefirst degree of radial interference at the first portion 80. In FIGS. 3and 4 the degree of radial interference is approximately indicatedgraphically by the thickness of the cross-hatching defining the radialinterference region 78 in the respective portion. As can be seen, theradial interference in the second portion 82, and particularly in theannular regions of the second portion defined by the relatively raisedsurface areas 74, is significantly less than in the first portion 80. Inone such embodiment, the second degree of radial interference at leastat the relatively raised surface areas 74 is approximately zero or less.As can be seen in the illustrated embodiment, the second portion 82defining the lesser degree of radial interference 78 is locatedoutwardly on the one-way valve 24 relative to the first portion 80. Whena dose of substance is dispensed through the seam 30 of the one-wayvalve 24, the valve cover 28 may initially stick to the valve seat 26,thus creating a build-up of pressure within the valve. The second region82 of the seam absorbs and/or dissipates the energy resulting from anysuch pressure build-up, and in turn substantially prevents the dose fromspritzing upon emission from the valve. In ophthalmic applications, thedose is preferably delivered as a drop that falls from the dispensingtip into a user's eye. As shown, the valve cover 28 defines a relativelyraised portion 74 rather than a recessed portion 76 at the distal end ofthe valve cover 28 to ensure formation of a seal at this region and thussubstantially prevent the collection of residue that otherwise mightbecome contaminated between usages.

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein the anti-spritzing feature may take any ofnumerous different configurations that are currently known, or thatlater become known for performing this function. For example, as shownin the alternative embodiment of FIGS. 5 and 6, the relatively raisedportions 74 and adjacent relatively recessed portions are formed on thevalve seat 26 rather than on the valve cover 28. Also in thisembodiment, the relatively raised and recessed surface portions 74, 76extending axially throughout substantially the entire seam 30 of theone-way valve 24. The degree of radial interference may be the same forthe relatively raised surface areas, and for the relatively recessedsurface areas, but greater for the recessed surface areas 76 then forthe raised surface areas 74. However, the degree of radial interferencemay be varied as desired or otherwise required to achieve theanti-spritzing objective. In addition, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, thesurface features may take any of numerous different configurations thatare currently known, or that later become known for purposes ofachieving the anti-spritzing function, while nevertheless maintaining afluid-tight seal in the normally-closed position.

In a currently preferred embodiment of the present invention, theplunger 40 includes a needle penetrable and resealable stopper or likeportion 72 that permits the variable-volume storage chamber 14 to beneedle filled with a substance therethrough, and that allows theresulting needle hole to be thermally resealed, such as by applicationof laser energy thereto. In the illustrated embodiment, the stopper 72is co-molded with the body of the plunger, such as by over-molding thestopper to the body. The needle penetrable and resealable portion of theplunger or resealable stopper or like portion 72 thereof (or otherdesired needle penetrable and thermally resealable portion of thedispenser), may be formed with any of the various materials disclosedin, and may be needle filled and resealed in accordance with the variousteachings of, the following patents and co-pending patent applicationsthat are assigned to the Assignee of the present invention and arehereby expressly incorporated by reference in their entireties as partof the present disclosure: U.S. Pat. No. 6,604,561, entitled “MedicamentVial Having a Heat-Sealable Cap, and Apparatus and Method for Fillingthe Vial”; U.S. Pat. No. 6,684,916, entitled “Medicament Vial Having aHeat-Sealable Cap, and Apparatus and Method for Filling the Vial”; U.S.Pat. No. 6,805,170, entitled “Medicament Vial Having a Heat-SealableCap, and Apparatus and Method for Filling the Vial”; U.S. Pat. No.7,243,689, entitled “Medicament Vial Having a Heat-Sealable Cap, andApparatus and Method for Filling the Vial”; U.S. Pat. No. 7,032,631,entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus andMethod for Filling the Vial”; U.S. patent application Ser. No.11/879,485 filed Jul. 16, 2007, entitled “Device with Needle Penetrableand Laser Resealable Portion and Related Method”; U.S. Pat. No.6,929,040, entitled “Sterile Filling Machine Having Needle Fillingwithin E-Beam Chamber”; U.S. Pat. No. 7,111,649, entitled “SterileFilling Machine Having Needle Filling within E-Beam Chamber”; U.S.patent application Ser. No. 11/527,775 filed Sep. 25, 2006, entitled“Sterile Filling Machine Having Needle Filling within E-Beam Chamber”;U.S. Pat. No. 7,100,646, entitled “Sealed Containers and Methods ofMaking and Filling Same”; U.S. patent application Ser. No. 11/515,162filed Sep. 1, 2006, entitled “Sealed Containers and Method of making andFilling Same; U.S. provisional patent application Ser. No. 60/518,685,filed Nov. 10, 2003, entitled “Needle Filling and Laser SealingStation”: U.S. patent application Ser. No. 10/983,178 filed Nov. 5,2004, entitled “Needle Filling and Laser Sealing Station; U.S. Pat. No.7,096,896, entitled “Apparatus for Needle Filling and Laser Resealing”;U.S. patent application Ser. No. 11/510,961 filed Aug. 28, 2006;entitled “Apparatus for Needle Filling and Laser Resealing”; and U.S.patent application Ser. No. 11/901,467 filed Sep. 17, 2007 entitled“Apparatus for Needle Filling and Laser Resealing”; and U.S. patentapplication Ser. No. 11/339,966, filed Jan. 25, 2006, entitled“Container Closure with Overlying Needle Penetrable and ThermallyResealable Portion and Underlying Portion Compatible with Fat ContainingLiquid Product, and Related Method.”

The re-sealable stopper 72 is formed of a thermoplastic materialdefining a needle penetration region that is pierceable with a needle toform a needle aperture therethrough, and is heat re-sealable tohermetically seal the needle aperture by applying laser radiation at apredetermined wavelength and power thereto. The stopper 72 includes athermoplastic body defining (i) a predetermined wall thickness in anaxial direction thereof, (ii) a predetermined color and opacity thatsubstantially absorbs the laser radiation at the predeterminedwavelength and substantially prevents the passage of the radiationthrough the predetermined wall thickness thereof, and (iii) apredetermined color and opacity that causes the laser radiation at thepredetermined wavelength and power to hermetically seal the needleaperture formed in the needle penetration region thereof in apredetermined time period and substantially without burning the needlepenetration region (i.e., without creating an irreversible change inmolecular structure or chemical properties of the material). In someembodiments, the predetermined time period is approximately 2 seconds,is preferably less than or equal to about 1.5 seconds, and mostpreferably is less than or equal to about 1 second. In some of theseembodiments, the predetermined wavelength of the laser radiation isabout 980 nm, and the predetermined power of each laser is less thanabout 30 Watts, and preferably less than or equal to about 10 Watts, orwithin the range of about 8 to about 10 Watts. Also in some of theseembodiments, the predetermined color of the material is gray, and thepredetermined opacity is defined by a dark gray colorant (or pigment)added to the stopper material in an amount within the range of about0.3% to about 0.6% by weight.

In addition to the thermoplastic materials described above, thethermoplastic material of the stopper 72 may be a blend of a firstmaterial that is preferably a styrene block copolymer, such as thematerials sold under either the trademarks KRATON or DYNAFLEX, such asDYNAFLEX G2706-10000-00, or GLS 230-174 (Shore A=30), and a secondmaterial that is preferably an olefin, such as the materials sold undereither the trademarks ENGAGE or EXACT, such as EXACT 8203, or GLS230-176 (Shore A=42). In some embodiments, the first and secondmaterials are blended within the range of about 50:50 by weight topreferably about 90:10 by weight, and most preferably about 90:5 byweight (i.e., first material:second material). The benefits of thepreferred blend over the first material by itself are improved water orvapor barrier properties, and thus improved product shelf life; improvedheat sealability; a reduced coefficient of friction; improvedmoldability or mold flow rates; and a reduction in hystereses losses.

Alternatively, the thermoplastic material of the re-sealable stoppers 72may take the form of a styrene block copolymer sold by GLS Corporationof McHenry, Ill. under the designation LC 254-071. This type of styreneblock copolymer compound exhibits approximately the following physicalproperties: (i) Shore A Hardness: about 28-29; (ii) Specific Gravity:about 0.89 g/cm³; (iii) Color: approximately grey to dark grey; (iv)300% Modulus, flow direction: about 181-211 psi; (v) Tensile Strength atBreak, flow direction: about 429-498 psi; (vi) Elongation at Break, flowdirection: about 675%-708%; and (vii) Tear Strength, flow direction:about 78-81 lbf/in.

In each of these embodiments, the predetermined color and opacity of thethermoplastic is defined by a grey colorant that is provided in anapproximately 3% color concentrate (i.e., there is an approximately 33:1ratio of the concentrate to the natural resin or TPE). The colorconcentrate contains about 88.83% carrier or base resin, the remainderis pigment, and the pigment is grey carbon black. Thus, the pigment isabout 0.34% by weight of the resulting thermoplastic.

In addition, if desired, a lubricant of a type known to those ofordinary skill in the pertinent art may be added to or included withineach of the above-mentioned thermoplastic compounds, in order to preventor otherwise reduce the formation of particles upon penetrating theneedle penetration region of the thermoplastic stopper with a needle orother filling member. In one embodiment of the present invention, thelubricant is a mineral oil that is added to the styrene block copolymeror other thermoplastic compound in an amount sufficient to prevent, orsubstantially prevent, the formation of particles upon penetrating samewith the needle or other filling member. In another embodiment, thelubricant is a silicone, such as the liquid silicone sold by Dow CorningCorporation under the designation “360 Medical Fluid, 350 CST”, or asilicone oil, that is added to the styrene block copolymer or otherthermoplastic compound in an amount sufficient to prevent, orsubstantially prevent, the formation of particles upon penetrating samewith the needle or other filling member. In one such embodiment, thesilicone oil is included in an amount within the range of about 0.4% toabout 1% by weight, and preferably within the range of about 0.4 toabout 0.6% by weight, and most preferably within the range of about 0.51or about 0.5% by weight.

Alternatively, the resealable stopper or like portions of the dispensermay be made with one or more of the materials disclosed in internationalPCT patent application no. PCT/EP2004/008703, (WO2005/014419 A1), filedAug. 2, 2004, which claims priority to Great Britain patent applicationno. 031824.25, filed Aug. 4, 2003, each of which is hereby incorporatedby reference as part of the present disclosure.

After needle filling the storage chamber 14 through, and laser resealingthe stopper 72 of the plunger 40, a cap 84 is fixedly secured to theopen end of the body 12 to prevent access to the interior of the body.The cap 84 includes one or more vent apertures (not shown) to preventthe formation of a vacuum between the plunger 40 and cap 84, andotherwise to allow the plunger 40 to freely travel through the body 12upon dispensing the substance from the storage chamber 14.

Turning to FIGS. 7A-7D, the dispenser 10 may be needle filled and laserresealed by first sterilizing the interior of the sealed emptydispenser, such as by applying radiation thereto, such as gamma or ebeamradiation. The sealed, empty, sterile dispenser 10 is then placed in asuitable fixture (e.g., a filling tray), or is already placed in suchfixture during the sterilization step, so that the one-way valve 24 isfacing down, and the needle penetrable and thermally re-sealable stopper72 is facing up. Then, the stopper 72 is pierced with a non-coringneedle or cannula 86 and the cannula and stopper are driven downwardlyor inwardly from the “home” position, as shown in FIG. 7A, to the “startfill” position where the stopper and cannula are located at the innerend of the empty body 12, as shown in FIG. 7B. If desired, and as shownin broken lines in FIG. 7B, the needle 86 may include a collar 87fixedly secured thereto and located adjacent to the pointed tip forengaging the exterior surface of the stopper 40 to facilitate drivingthe stopper from the home to the start fill position and otherwiseprevent relative movement between the stopper and needle during thisstep. Then, as shown in FIG. 7B, the substance is injected through theneedle 86 and into the chamber 14. As can be seen in FIGS. 7C and 7D,the substance fills the variable-volume storage chamber 14, and thestopper 40 moves upwardly toward the back end of the body until thevariable-volume storage chamber is filled. In the embodiment employingthe collar 87 (FIG. 7B), the needle is driven upwardly with the stopperfrom the start fill position back to the home position (as shownprogressively in FIGS. 7B-7D) while the variable-volume storage chamberis filled due to the friction between the needle and stopper and thefluid pressure of the filled liquid against the stopper. Preferably, theretraction rate of the needle, and the fill rate of the fluid introducedinto the chamber through the needle, are set so that the chamber isfilled as the needle is withdrawn without causing a significant increasein fluid pressure, or a vacuum within the chamber. The needle 86 mayinclude within it a vent conduit (not shown) allowing fluid, such asair, to be exhausted from the variable-volume storage chambertherethrough, or if desired, to allow fluid, such as nitrogen or otherinert gas used as a purge, to be introduced into the variable-volumestorage chamber therethrough. In addition, the vent conduit may becoupled in fluid communication with a vacuum source to pull a vacuum onthe conduit, and in turn, draw fluid, such as air, out of thevariable-volume storage chamber prior to and/or during the fill toprevent pressurization of any such air within the variable-volumestorage chamber, and otherwise to remove air or other gases from thechamber. In one embodiment of the present invention, when the stopper 40returns to the home position as shown in FIG. 7D, the filling is timedso that some of the filled liquid is drawn into the vent conduit (eitherby flowing into the conduit, or by being drawn into the vent conduit bythe vacuum source) and/or into a container in fluid communication withthe conduit or filling needle, in order to fully fill thevariable-volume storage chamber and substantially prevent the formationof air pockets within the filled chamber. Any such significant airpockets can enter the dosage chamber of the pump, cause cavitation, andotherwise prevent dosing of filled liquid through the one-way valve. Ifdesired, the stopper can be fixed in the home position throughoutfilling (i.e., the stopper is not moved during filling), and the needlecan fill from a fixed position, or may be moved through the stopperduring filling to perform a “bottom up” fill.

As shown in FIG. 8A, in the home position, a stop 89 of the fillingapparatus is preferably received within the open end of the body 12 toengage the stopper 40 in the home position and thereby ensure properpositioning of the stopper and prevent the stopper from movement out ofthe body. As shown in FIG. 8A, in the home position, the needle 86 iswithdrawn, and then as shown in FIG. 8B, a laser source 91 is activatedto thermally reseal the resulting penetration aperture. Then, as shownin FIG. 8C, the cap 84 is installed to lock the stopper within the body.The cap 84 is snap fit into the back end of the body such that it cannotbe removed from the body without breaking the cap to thereby provide atamper-evident closure. If desired, the variable-volume storage chamber14 may be over-filled by an amount approximately equal to the volume ofthe dosage chamber. Then, prior to installing the cap 84, the dispensermay be turned upwardly so that the one-way valve 24 is facing up, andthe cap may be inserted into the back end of the body to, in turn, movethe plunger 40 upwardly. The cap 84 may include a projection (not shown)on its interior side to effect this movement of the plunger uponattachment of the cap to the body. This, in turn, displaces asubstantially predetermined amount of substance from the variable-volumestorage chamber 14 into the dosage chamber 18 to fill the dosage chamberwith substance and thereby prime the dispenser for the first dose.Orienting the dispenser in an upright position during this step willfacilitate in allowing any air or other gas within the dosage chamber tobe exhausted through the one-way valve 24 upon movement of the substanceinto the dosage chamber. If desired, the plunger 40 may be maintained ina fixed position on the body (i.e., at the back end 90 of the body)during needle filling rather than moving the plunger during filling.

As shown in FIGS. 9 and 10A-10F, the dispenser 10 is actuated todispense a drop of substance, such as an ophthalmic formulation, byengaging, such as with the index finger, the actuator 22 and depressingthe actuator (FIG. 9). As indicated in FIG. 10B, depression of theactuator 22 pressurizes the substance within the dosage chamber 18 and,in turn, releases the dose in drop form through the one-way valve 24.Simultaneously, and as indicated in FIGS. 10B and 10C, the slidingpiston 40 moves forward to compensate for the dispensed dose, and allowsthe next dose to flow into the dosage chamber. As shown in FIGS. 10D-10Fand 11, as additional dosages are dispensed, the sliding stopper 40progressively moves inwardly within the body 12 until thevariable-volume storage chamber is emptied (FIG. 11)

If desired, and as shown in broken lines in FIG. 2, the dispenser 10 mayfurther include a flexible membrane 88 coupled between the piston 40 andan end portion 90 of the body 12 opposite the dispensing portion, andforming a substantially fluid-tight seal between the annular piston andrespective end portion of the body. If desired, the flexible membrane 88may include a plurality of laminated layers to provide desiredproperties, such as desired barrier properties. Also in the illustratedembodiment, the flexible membrane 88 extends annularly about the piston40 and about the respective end portion 90 of the body to effect afluid-tight seal between the plunger and the ambient atmosphere. Asshown typically in FIG. 9, the dispensing portion may include aplurality of axially elongated ribs 92 and axially elongated slotsformed between the ribs, located on an opposite side of the dispensingportion 16 relative to the actuator 22 to provide a gripping surface.Also, the slots allow the wall thickness in this region of thedispensing portion to be reduced and thereby prevent the formation ofsink holes in this relatively thick region of the part during molding.

Turning to FIGS. 12 and 13, another dispenser embodying the presentinvention is indicated generally by the reference numeral 110. Thedispenser 110 is substantially similar to the dispenser 10 describedabove, and therefore like reference numerals preceded by the numeral “1”instead are used to indicate like elements. The primary difference ofthe dispenser 110 is that the body 112 is formed by a collapsible tube,and the dispensing tip defines a more axially-elongated or pointedconfiguration. In this embodiment, the body defines a tube head 113 thatis preferably co-molded, such as by insert molding to the tube body 112.Also in this embodiment, each outlet aperture 120 is defined in part byan axially-elongated channel 121 that defines a progressively decreasingdepth in the direction from the inner toward the outer end of the valve124, and terminates at the seam 130 of the valve. The channel 121 mayfacilitate the flow of relatively viscous substances into and throughthe valve 124, such as creams and gels. In the illustrated embodiment,the dispenser 110 includes three outlet apertures 120 and correspondingchannels 121 approximately equally spaced relative to each other aboutthe valve seat 126. Also in the this embodiment, the securing member 152extends axially along the valve cover 128; however, the distal portionof the valve cover extends outwardly of the securing member. In thisembodiment, the collapsible tube 112 is filled through the open backend, and is then sealed (such as by ultrasonic sealing), in a mannerknown to those of ordinary skill in the pertinent art. To sterile fillthe tube, and overpressure of sterile air or other gas may be providedduring filling through the open back end of the tube.

The collapsible tube 112 of this embodiment may be constructed inaccordance with the teachings of the following co-pending patentapplications which are assigned to the Assignee of the presentinvention, and are hereby expressly incorporated by reference in theirentireties as part of the present disclosure: U.S. Pat. No. 6,892,906,entitled “Container And Valve Assembly For Storing And DispensingSubstances, And Related Method”. U.S. patent application Ser. No.10/976,349 filed Oct. 28, 2004, entitled “Container And Valve AssemblyFor Storing And Dispensing Substances, And Related Method”, U.S. Pat.No. D503,611, entitled “Container and Valve Assembly”, U.S. Pat. No.D505,627, entitled “Tube and Valve Assembly”, U.S. Pat. No. D515,436,entitled “Tube”; U.S. Pat. No. D538,158, entitled Tube and ValveAssembly; U.S. patent application Ser. No. 29/273,719 filed Mar. 12,2007, entitled Tube and Valve Assembly, U.S. patent application Ser. No.60/528,429, filed Dec. 10, 2003, entitled “Valve Assembly And Tube KitFor Storing And Dispensing Substances, And Related Method,” U.S. patentapplication Ser. No. 60/539,602, filed Jan. 27, 2004, entitled “TubularContainer And One-Way Valve Assembly For Storing And DispensingSubstances, And Related Method; U.S. patent application Ser. No.11/008,887, filed Dec. 9, 2004, entitled “Container And One-Way ValveAssembly For Storing And Dispensing Substances, And Related Method”.

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, the variable-volume storage chamber maybe formed in any of numerous different ways that are currently known, orthat later become known, including, for example, by using a relativelyflexible bladder mounted within a relatively rigid body. Thevariable-volume storage chambers formed with a flexible bladder may beconstructed in accordance with the teachings of the following co-pendingpatent application which is assigned to the Assignee of the presentinvention, and is hereby expressly incorporated by reference in itsentirety as part of the present disclosure: U.S. application Ser. No.10/843,902, filed May 12, 2004, entitled “Dispenser and Apparatus andMethod for Filling a Dispenser”; and U.S. application Ser. No.11/349,873, filed Feb. 8, 2006, entitled “Dispenser and Apparatus andMethod for Filling a Dispenser”.

Turning to FIG. 14, another dispenser embodying the present invention isindicated generally by the reference numeral 210. The dispenser 210 issubstantially similar to the dispensers 10 and 110 described above, andtherefore like reference numerals preceded by the numeral “2”, orpreceded by the numeral “2” instead of the numeral “1”, are used toindicate like elements. A primary difference of the dispenser 210 incomparison to the dispenser 10 above, is that the sliding stopper 240includes in addition to the axially-spaced, relatively rigid annularsealing portions 242, a relatively flexible annular sealing portion 292.As can be seen, like the relatively rigid annular sealing portions 242,the relatively flexible annular sealing portion 292 forms aninterference fit with the inner wall 244 of the body to form a hermeticseal therebetween. A first annular gap 294 is formed between theflexible sealing portion 292 and rigid sealing portion 242 to allowdeformation of the flexible sealing portion therein during movement ofthe stopper. A second annular gap 296 is formed between the penetrableand thermally resealable stopper 272 and the flexible annular sealingportion 292. In the illustrated embodiment, a relative rigid supportwall 298 is formed integral with the relatively rigid sealing portions292 and extends axially adjacent to the second annular gap 296 tosupport and prevent creep of the flexible sealing portion 292. In theillustrated embodiment, the stopper 272 and flexible sealing portion 292are co-molded with the relatively rigid portions 242, such as byover-molding the flexible portion to the rigid portion. The secondannular gap 296 allows the molding gate to be located at approximatelythe center of the part, to relatively tightly control the tolerance ofthe outer diameter of the flexible sealing portion 292, and thus theconsistency of the hermetic seal from one part to another, and to form arelatively thick stopper portion 272 to, in turn, form a relativelythick layer of homogenous material within the penetration depth of thelaser and facilitate the formation of a hermetic laser reseal.

With respect to the relatively rigid sealing portions 242, the leadingcontact point (to the left in FIG. 14) is defined by the point oftangency between the radius of the relatively rigid sealing portion andthe inner wall of the body, and the trailing contact point (to the rightin FIG. 14) is defined by a point at the trailing edge of the part tominimize any frictional contribution and provide balance. The rigidportion of the stopper 240 defines plural flow paths 299 angularlyspaced relative to each other about the central region of the stopper toallow any trapped air to flow out of the mold therethrough duringmolding, and thereby prevent the formation of air pockets within theflexible portions of the stopper. The rigid portion of the stopper maybe made of any of numerous different materials that are currently known,or that later become known, such as a relatively rigid polyethylene. Theflexible portion of the stopper, on the other hand, may be made of anyof the materials described above for purposes of penetrating with afilling member and thermally resealing, or any of numerous othermaterials that are currently known, or that later become known for thispurpose. The body 212 defines a first region 300 that tapers inwardlytoward the inner end of the body to provide progressively moreinterference between the stopper and body as the stopper moves inwardlywithin the body. In the illustrated embodiment, the taper is about 0.5degrees; however, other taper angles equally may be employed. The taperregion 300 constitutes about one-half the length of the chamber (or theoverall travel distance of the stopper). The other inner of the innerwall 244 defines a substantially zero taper.

As also may be recognized by those of ordinary skill in the pertinentart based on the teachings herein, the dispensing tip may take any ofnumerous different configurations to perform any of numerous differentfunctions that are currently known or that later become known. Forexample, the contour of the dispensing tip may be shaped to comformablycontact a user's lips for purposes of applying a dose of liquidlipstick, other cosmetic, pharmaceutical, or other cosmetic substancethereto. As another example, the dispensing tip may take any of avariety of different forms designed to substantially conformably contacta user's eyelids, eyebrows, eyelashes, cheeks, toenails, fingernails,etc., or to deliver fluids or other substances in any desired manner.The dispensing tip may be shaped to effectively deliver ophthalmicproducts, such as eye drops, in a manner that releases the drop at asubstantially predetermined location on the tip, and that allowssubstantially the entire dosage to be released, to thereby facilitate asubstantially consistent drop size or volume from one dosage to thenext. Alternatively, the dispensing tip may be configured to deliversubstances to any desired body surface or cavity, including, forexample, dispensing tips that are configured to deliver dosages to thenasal, car (i.e., otic delivery), vaginal, penis and/or anal cavities,dispensing tips configured to deliver dosages to the scalp, ordispensing tips configured to deliver dosages to fingernails and/or toenails, including dispensing tips configured to deliver substancesunderneath the nails, on the tops of the nails, or to the cuticles ofthe nails. In another exemplary embodiment, the dispenser is configuredto dispense food or beverage products, including, for example,flavorings for coffee or other beverages. In some such embodiments, thedispensing tip may be shaped to facilitate insertion into, or engagementby a user's mouth for dispensing the product into the mouth. In othersuch embodiments, the dispensing tip may be shaped to facilitatedispensing the respective product into a cup or other beverage or foodproduct container. Accordingly, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, thespecific shape and/or configuration of the dispensing tip and/or of anapplicator surface of the dispensing tip, may take any of numerousdifferent shapes or configurations that are currently known, or thatlater become known for performing any of numerous different functions,and/or to address the requirements of any of numerous differentapplications of the dispensers for delivering any of numerous differentsubstances that are currently known, or that later become known.

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, numerous other changes and modificationsmay be made to the above-described and other embodiments of the presentinvention without departing from the scope of the invention as definedin the claims. For example, the components of the dispensers may be madeof any of numerous different materials that are currently known, or thatlater become known for performing the function(s) of each suchcomponent. Similarly, the components of the dispensers may take any ofnumerous different shapes and/or configurations. Also, the dispensersmay be used to dispense any of numerous different types of fluids orother substances for any of numerous different applications, including,for example, cosmetic, dermatological, ophthalmic or otherpharmaceutical, cosmeceutical, OTC food and/or beverage applications. Inaddition, the characteristics of the dispensers may be adjusted,including for example the shape and/or configuration of the dispensingtip, the volume of the dosages, and/or the valve opening pressure, tomeet the requirements of any of numerous different applications and/orproducts to be dispensed, including without limitation products that aredelivered topically, such as to the skin or to mucous membranes,products that are delivered to the ear (i.e., otic delivery), to thepenis, nasally, vaginally, anally or orally. In addition, the dispensersmay be actuated other than manually. For example, the dispenser may bemounted in a dispensing machine, and automatically actuated, such as bya solenoid, solenoid-driven actuator, or actuated by depressing amanually-engageable button or other actuator that, in turn, depresses anelastic or other actuator to dispense doses of substance, such as aflavoring, into a beverage container. Further, the filling machines andprocesses used to fill the dispensers of the present invention may takeany of numerous different configurations that are currently known, orthat later become known for filling the dispensers. For example, thefilling machines may have any of numerous different mechanisms forsterilizing, feeding, evacuating and/or filling the dispensers. Ifdesired, the surface contour of the valve seat may be adjusted tofacilitate directing the valve-flow through a predetermined dispensinglocation at the valve tip. In addition, rather than use the needlepenetrable and resealable actuator, plunger, or other like stopper, thedispenser may employ a filling valve as disclosed in the followingpatent application that is assigned to the Assignee of the presentinvention, and is hereby incorporated by reference in its entirety aspart of the present disclosure: U.S. application Ser. No. 10/843,902,filed May 12, 2004, titled “Dispenser and Apparatus and Method forFilling a Dispenser”; and U.S. application Ser. No. 11/349,873, filedFeb. 8, 2006, entitled “Dispenser and Apparatus and Method for Filling aDispenser”. In such alternative embodiments, the filling valve mayextend through the body or otherwise may be coupled in fluidcommunication with the storage chamber to evacuate and/or fill thestorage chamber. Alternatively, the dispenser may include one valve forevacuating the interior of the dispenser and another valve for fillingthe storage chamber of the dispenser. Still further, the valves each maytake a configuration that is different than that disclosed herein.Accordingly, this detailed description of currently preferredembodiments is to be taken in an illustrative, as opposed to a limitingsense.

What is claimed is:
 1. A dispenser for dispensing a substance,comprising: a body including a variable-volume storage chamber forstoring the substance; a dispensing portion connected with the body anddefining a dosage chamber coupled in fluid communication with thestorage chamber for receiving substance therefrom, and an outletaperture coupled in fluid communication with the dosage chamber; a firstvalve forming an external portion of the dispenser and including a valveseat and a flexible valve cover seated on the valve seat defining aninterference fit therewith and defining a normally-closed seamtherebetween forming a fluid-tight seal between the valve cover andvalve seat, wherein the flexible valve cover is movable relative to thevalve seat and the seam is connectable in fluid communication with theoutlet aperture to allow the passage of substance through the seam andout of the dispenser; a second valve coupled in fluid communicationbetween the dosage chamber and the storage chamber that allows the flowof substance from the storage chamber into the dosage chamber andsubstantially prevents the flow of substance from the dosage chamberinto the storage chamber; and an elastic actuator mounted on thedispensing portion and movable between (i) a first non-actuatedposition, and (ii) a second actuated position for compressing a dose ofsubstance within the dosage chamber and, in turn, dispensing thesubstance through the first valve, wherein the actuator is configured tobe actuated in a direction between the first non-actuated position andthe second actuated position that is transverse to an axis of the firstvalve, the elasticity of the actuator causes the actuator to return fromthe second actuated position to the first non-actuated position uponreleasing the actuator, and the actuator is in fluid communication withthe dosage chamber, extends axially in a direction approximatelyparallel to an axis of symmetry of the dispenser, extends angularlyabout the axis of symmetry, and in the second actuated position extendsinto the dosage chamber.
 2. A dispenser as defined in claim 1, whereinthe dispensing portion includes a dispensing body defining the dosagechamber, outlet aperture and valve seat, and the elastic actuator isco-molded to the dispensing body.
 3. A dispenser as defined in claim 1,wherein the elastic actuator extends angularly through an arc within therange of about 50° to about 80°.
 4. A dispenser as defined in claim 1,wherein the elastic actuator defines a manually-engageable surfacelocated a substantially uniform distance from the axis of symmetry inthe non-actuated position.
 5. A dispenser as defined in claim 1, whereinthe body forms the storage chamber and includes a flexible tube.
 6. Adispenser as defined in claim 1, further comprising a stopper slidablyreceived within the body and forming a substantially fluid-tight sealtherebetween, wherein the variable-volume storage chamber is formedbetween the stopper and the dosage chamber, and the stopper is movabletoward the dosage chamber upon dispensing a dosage from the storagechamber to reduce the volume of the storage chamber in an amountapproximately equal to the volume of the dose dispensed.
 7. A dispenseras defined in claim 6, further comprising a flexible membrane coupledbetween the stopper and an end portion of the body opposite thedispensing portion, and forming a substantially fluid-tight seal betweenthe stopper and respective end portion of the body.
 8. A dispenser asdefined in claim 7, wherein the flexible membrane includes a pluralityof laminated layers.
 9. A dispenser as defined in claim 7, wherein theflexible membrane extends annularly about the stopper and about therespective end portion of the body.
 10. A dispenser as defined in claim7, wherein the stopper includes at least one relatively rigid annularsealing portion forming an interference fit with the body, and at leastone relatively flexible annular sealing portion forming an interferencefit with the body and a fluid-tight seal therebetween.
 11. A dispenseras defined in claim 10, wherein the relatively rigid and relativelyflexible portions are co-molded.
 12. A dispenser as defined in claim 11,wherein the relatively flexible portion further defines a penetrable andresealable portion that is penetrable by a filling member to fill thevariable-volume storage chamber and is resealable to reseal an aperturetherein.
 13. A dispenser as defined in claim 12, wherein the flexiblesealing portion is substantially concentric with the penetrable portion,and a gap is formed therebetween.
 14. A dispenser for dispensing asubstance, comprising: a body including a variable-volume storagechamber for storing the substance; a dispensing portion connected withthe body and defining a dosage chamber coupled in fluid communicationwith the storage chamber for receiving substance therefrom, and anoutlet aperture coupled in fluid communication with the dosage chamber;a first valve forming an external portion of the dispenser and includinga valve seat and a flexible valve cover seated on the valve seatdefining an interference fit therewith and defining a normally-closedseam therebetween forming a fluid-tight seal between the valve cover andvalve seat, wherein the flexible valve cover is movable relative to thevalve seat and the seam is connectable in fluid communication with theoutlet aperture to allow the passage of substance through the seam andout of the dispenser; a second valve coupled in fluid communicationbetween the dosage chamber and the storage chamber that allows the flowof substance from the storage chamber into the dosage chamber andsubstantially prevents the flow of substance from the dosage chamberinto the storage chamber; and an elastic actuator mounted on thedispensing portion and movable between (i) a first non-actuatedposition, and (ii) a second actuated position for compressing a dose ofsubstance within the dosage chamber and, in turn, dispensing thesubstance through the first valve, wherein the actuator is configured tobe actuated in a direction between the first non-actuated position andthe second actuated position that is transverse to an axis of the firstvalve, and wherein the elasticity of the actuator causes the actuator toreturn from the second actuated position to the first non-actuatedposition upon releasing the actuator, wherein at least one of the valvecover and the valve seat defines at least one relatively raised surfacearea and at least one adjacent relatively recessed surface area forsubstantially preventing spritzing of a dose of substance upon emissionfrom the first valve.
 15. A dispenser as defined in claim 14, wherein atleast one of the valve cover and the valve seat defines at the seam aplurality of relatively raised surface areas and relatively recessedsurface areas adjacent to the relatively raised surface areas.
 16. Adispenser as defined in claim 14, wherein the at least one relativelyraised surface area is defined by an annular ring, and the at least onerelatively recessed surface area is defined by an annular groove.
 17. Adispenser as defined in claim 14, wherein the valve cover includes afirst portion defining a first degree of interference with the valveseat in the normally closed position, and a second portion spacedrelative to the first portion defining a second degree of interferencewith the valve seat in the normally closed position, wherein the seconddegree of interference is less than the first degree of interference.18. A dispenser for dispensing a substance, comprising: first means forforming a variable-volume storage chamber for storing the substance;second means for forming a dosage chamber coupled in fluid communicationwith the storage chamber for receiving substance therefrom, and anoutlet aperture coupled in fluid communication with the dosage chamber;third means for forming an external portion of the dispenser and forforming a normally-closed seam defining an interference fit and coupledin fluid communication with the second means and movable in response tothe flow of pressurized substance from the second means into the seam toallow the passage of substance through the seam and out of thedispenser; fourth means coupled in fluid communication between thedosage chamber and the storage chamber for allowing the flow ofsubstance from the storage chamber into the dosage chamber andsubstantially preventing the flow of substance from the dosage chamberinto the storage chamber; and fifth means for engaging and elasticallymoving between (i) a first non-actuated position, and (ii) a secondactuated position for compressing a dose of substance within the dosagechamber and, in turn, dispensing the substance through the third means,for being actuated in a direction between the first non-actuatedposition and the second actuated position that is transverse to an axisof the third means, for elastically returning from the second actuatedposition to the first non-actuated position upon releasing the fifthmeans, for being in fluid communication with the second means, forextending axially in a direction approximately parallel to an axis ofsymmetry of the dispenser, for extending angularly about the axis ofsymmetry, and for extending into the second means in the second actuatedposition.
 19. A dispenser as defined in claim 18, wherein the firstmeans is a body portion of the dispenser; the second means is adispensing portion connected with the body and defining a dosage chambercoupled in fluid communication with the storage chamber for receivingsubstance therefrom, and an outlet aperture coupled in fluidcommunication with the dosage chamber; the third means is a first valveincluding a valve seat and a flexible valve cover seated on the valveseat and defining a normally-closed seam therebetween forming afluid-tight seal between the valve cover and valve seat, wherein theflexible valve cover is movable relative to the valve seat and the seamis connectable in fluid communication with the outlet aperture to allowthe passage of substance through the seam and out of the dispenser; thefourth means is a second valve coupled in fluid communication betweenthe dosage chamber and the storage chamber that allows the flow ofsubstance from the storage chamber into the dosage chamber andsubstantially prevents the flow of substance from the dosage chamberinto the storage chamber; and the fifth means is an elastic actuatormounted on the dispensing portion in fluid communication with the dosagechamber and movable between (i) a first non-actuated position, and (ii)a second actuated position for compressing a dose of substance withinthe dosage chamber and, in turn, dispensing the substance through thefirst valve.
 20. A dispenser for dispensing a substance, comprising:first means for forming a variable-volume storage chamber for storingthe substance; second means for forming a dosage chamber coupled influid communication with the storage chamber for receiving substancetherefrom, and an outlet aperture coupled in fluid communication withthe dosage chamber; third means for forming an external portion of thedispenser and for forming a normally-closed seam defining aninterference fit and coupled in fluid communication with the secondmeans and movable in response to the flow of pressurized substance fromthe second means into the seam to allow the passage of substance throughthe seam and out of the dispenser; fourth means coupled in fluidcommunication between the dosage chamber and the storage chamber forallowing the flow of substance from the storage chamber into the dosagechamber and substantially preventing the flow of substance from thedosage chamber into the storage chamber; and fifth means for engagingand elastically moving between (i) a first non-actuated position, and(ii) a second actuated position for compressing a dose of substancewithin the dosage chamber and, in turn, dispensing the substance throughthe third means, for being actuated in a direction between the firstnon-actuated position and the second actuated position that istransverse to an axis of the third means and for elastically returningfrom the second actuated position to the first non-actuated positionupon releasing the fifth means; and sixth means for substantiallypreventing the substance from spritzing upon being dispensed from thethird means.
 21. A dispenser as defined in claim 20, wherein the sixthmeans is defined by at least one of a valve cover and a valve seatdefining at a seam formed therebetween at least one relatively raisedsurface area and at least one adjacent relatively recessed surface area.22. A dispenser as defined in claim 18, further comprising a slidingstopper received within the first means and forming the variable-volumestorage chamber therein, wherein the sliding stopper includes relativelyrigid means for slidably contacting the first means and forming a sealtherebetween, and relatively flexible means for slidably contacting thefirst means and forming a seal therebetween.
 23. A dispenser as definedin claim 22, wherein the relatively flexible means also is penetrableand resealable for filling the variable-volume storage chambertherethrough and sealing an aperture in the relatively flexible means.24. A dispenser as defined in claim 19, wherein the valve seat and valvecover are axially-extending, and the seam defined thereby is anaxially-extending seam.
 25. A dispenser as defined in claim 1, whereinthe valve seat and valve cover are axially-extending, and the seamdefined thereby is an axially-extending seam.
 26. A dispenser as definedin claim 1, further comprising a penetrable and resealable portion thatis penetrable by a filling member to fill the variable-volume storagechamber and is resealable to reseal an aperture therein.
 27. A dispenseras defined in claim 1, wherein the storage chamber is defined by one ofa flexible tube and a flexible bladder.
 28. A dispenser as defined inclaim 27, wherein the body is relatively rigid and the storage chamberis mounted within the body.
 29. A dispenser as defined in claim 12,wherein the resealable portion is thermally resealable by applying atleast one of thermal energy and laser radiation thereto.
 30. A dispenseras defined in claim 23, wherein the relatively flexible means isthermally resealable by applying at least one of thermal energy andlaser radiation thereto.
 31. A dispenser as defined in claim 17, whereinthe second portion is located toward an exterior of the first valverelative to the first portion.
 32. A dispenser as defined in claim 1,wherein during dispensing of the substance through the first valve,respective segments of the valve cover at least one of (i) substantiallysequentially move relative to the valve seat to allow the passage ofsubstance through the seam and out of the dispenser; and (ii)substantially progressively open and then close after passage ofsubstance therethrough when moving toward an exterior of the firstvalve.
 33. A dispenser as defined in claim 1, wherein at substantiallyany time during dispensing of the substance through the first valve, atleast one segment of the valve cover substantially engages the valveseat.
 34. A dispenser as defined in claim 1, wherein the valve coverincludes a first portion defining a first degree of interference withthe valve seat in the normally closed position, and a second portiondefining a second degree of interference with the valve seat in thenormally closed position.
 35. A dispenser as defined in claim 1, whereinat least one of (i) the valve cover defines a generally taperedcross-sectional shape in a direction from an interior toward an exteriorof the first valve; (ii) segments of the valve cover requireprogressively less energy to open in a direction from an interior towardan exterior of the first valve; and (iii) the valve seat defines anincreasing outer diameter in a direction from an interior toward anexterior of the first valve.
 36. A dispenser as defined in claim 1,wherein the valve cover extends annularly about the valve seat.